The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

The first book on the ethical, legal, and social concerns raised by human microbiome research.

Calls for research ethics reform, including relaxed consent requirements.

Addresses the need for thoughtful policies and procedures to guide the use of the large number of biobanked human samples required for advancing this new domain of human microbiome research.

Relates to a number of ongoing debates and controversies, including regulation of human subject research and epidemic preparedness.

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Description

The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and our microbiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how much we are a part of our environment. The understanding that microbes are not only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly.

This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiome research challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examples from the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.

This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group.

"The microbiome is a relatively new area of medical attention. Ethical issues related to the microbiome have barely been identified, much less carefully analyzed. This volume is an excellent start toward that ethical analysis. Many of the arguments are persuasive and provocative. In particular, some contributors challenge the ethical need for anonymizing microbiome specimens as well as the need for individual informed consent for specific uses of these specimens. I highly recommend this volume for all those interested in the microbiome and in new frontiers in medical ethics." -Leonard M. Fleck, Michigan State University

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Table of Contents

AcknowledgementsIntroduction: Looking Back and Looking ForwardRosamond Rhodes The Project Collaborators The Scope of this Volume Reading this Book

1. The Human Microbiome: Science, History and ResearchLily E. Frank, Martin J. Blaser, Kurt Hirschhorn, Daniel A. Moros, Matthew E. Rhodes, Sean PhilpottIntroduction: Microbes and MicrobiologyThe Role of Microorganisms in the EnvironmentThe Use of Microorganism in Industry and Food ProductionThe History of Microorganisms in Human Health and DiseaseThe Human Microbiome Human Microbiome Project and the National Institute of Health Research Tools and Methods Acquisition of the Microbiome Interactions between the Microbiome and the Host Genome Manipulating the Microbiome for Medical PurposesConclusions

3. Property and Research on the Human MicrobiomeMary Ann Baily, Abraham P. Schwab, Joseph Goldfarb, Kurt Hirschhorn, Rosamond Rhodes, Brett Trusko Four Controversial Cases Introduction Ownership and Property in Philosophy Ownership and Property in the Social Sciences Ownership and Property in the Context of Biomedical Research Current Property Structures and Research on the Human Microbiome Patents Copyrights Property Rights and Biological Samples Henrietta Lacks and HeLa Cells John Moore's Leukemia Cells Conclusion Policy Recommendations

5. Research Ethics Rosamond Rhodes, Joseph W. Dauben, Lily E. Frank, Daniel A. Moros, Sean Philpott Introduction The Landscape of Microbiome Research Historical Development of Research Ethics Regulation and Guidelines Research Ethics and Human Microbiome ResearchCritical Reflections on the U.S. Framework for Human Subject Research Implications for the Conduct of Human Subject Microbiome Research Research on ProbioticsConclusionsPolicy Recommendations

7. Public Health and Research on Populations Rosamond Rhodes, Stefan Bernard Baumrin, Martin J. Blaser, William J. Earle, Debbie Indyk, Ethylin Wang Jabs, Daniel A. Moros, Lynne D. Richardson, Henry S. Sacks Microbes and Public Health Public Health, Liberty, and Privacy Public Health Functions Public Health Agency PowersPublic Health Methods Research Regulations and Public Health Data Gathering Quality Improvement, Quality Assurance and Surveillance De Minimis Risk: A Proposal for a New Category of Research Risk Additional Factors in the Ethical Conduct of Population Studies Prevention and Education Cautions for Public Health Policy Makers Coda: Further Philosophical Reflections on Public Health by William J. EarlePolicy Recommendations

GlossaryIndex

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Author Information

Rosamond Rhodes, Ph.D., is Professor of Medical Education and Director of Bioethics Education at Icahn School of Medicine at Mount Sinai, Professor of Philosophy at The Graduate Center, CUNY, and Professor of Bioethics and Associate Director of the Union-Mount Sinai Bioethics Program. She writes on a broad array of issues in bioethics.

Nada Gligorov, Ph.D., is Assistant Professor of Medical Education at Icahn School of Medicine at Mount Sinai and Assistant Professor of Bioethics at the Union- Mount Sinai Bioethics Program. She is primarily interested in neuroethics, most specifically determinism and free will as well as the impact of brain imaging technologies on privacy. She has also published on personal identity as it relates to biomedical issues such as advance directives.

Abraham Paul Schwab, Ph.D., is Assistant Professor of Philosophy at Indiana University-Purdue University Fort Wayne and an associate faculty member in the Union-Mount Sinai Bioethics Program.

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Reviews and Awards

"The authors, all members of the Microbiome Working Group, have brought their many years of experience and varied areas of expertise to bear on [social, ethical, and legal aspects of microbiome research], with an eye toward formulating guidelines and public policy recommendations that should prove useful as microbiome research ventures into increasingly uncharted territory in the coming years." -R.K. Harris, William Carey University, CHOICE

This anthology would be very useful for human microbiome researchers with little experience with medical ethics or philosophers with little knowledge of the human microbiome, although as a jumping-off point for further detailed examination of both sides of many issues. This is a solid first look at ethics and the human microbiome. -- The Quarterly Review of Biology

"This volume is a fine example of bioethics at its best." --Environmental Philosophy